Device, system and methods for introducing soft tissue anchors

ABSTRACT

A system for providing support to an anatomical structure of the pelvis includes first and second soft tissue anchors, a suburethral support, an introducer, and a filament. The first soft tissue anchor has a proximal end and a distal end and includes a base having a hollow tubular structure, a plurality of barbs, and a tip. The sub-urethral support portion has first and second ends, the first and second soft tissue anchors extending from the first and second ends of the sub-urethral support portion. The introducer has an elongate shaft and a handle, the elongate shaft having a proximal end at the handle and a distal end with an aperture extending through the distal end. The filament extends through the hollow tubular section of the first soft tissue anchor and through the aperture in the distal end of introducer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of pending U.S. application Ser. No.13/149,994 filed Jun. 1, 2011, and entitled SYSTEM FOR INTRODUCING SOFTTISSUE ANCHORS, which is a continuation of U.S. application Ser. No.12/837,601 filed Jul. 16, 2010, now U.S. Pat. No. 8,007,430, andentitled APPARATUS AND METHOD FOR TREATING FEMALE URINARY INCONTINENCE,which is a continuation of U.S. application Ser. No. 11/199,061 filedAug. 8, 2005, now U.S. Pat. No. 7,789,821, which in turn is acontinuation of U.S. application Ser. No. 10/398,992, filed Apr. 11,2003, now U.S. Pat. No. 6,960,160, which in turn is a national stageapplication under 35 U.S.C. 371 of International Application No.PCT/GB01/04554, filed Oct. 12, 2001, which in turn claims priority ofGreat Britain Application No. GB0025068.8, filed Oct. 12, 2000, thecontents of each of which are incorporated by reference herein for allpurposes.

This invention relates to an apparatus and method for treating femaleurinary incontinence and, in particular, to a surgical implant having asling that passes under the urethra in use and supports the urethra toalleviate incontinence, along with related apparatus and methods forinserting the surgical implant in the body.

Urinary incontinence affects a large number of women and, consequently,various approaches have been developed to treat female urinaryincontinence. Those skilled in the art will be familiar with approachesranging from pelvic floor exercises to surgical techniques such as Burchcolposuspension and Stamey-type endoscopic procedures in which thesutures are placed so as to elevate the bladder neck.

This invention is particularly directed to improvement of a knownprocedure in which a sling is positioned loosely under the urethra,commonly known as TVT (tension free vaginal tape) and described, forexample, in International Patent Applications No. WO97/13465 andWO97/06567. It is generally understood that this treatment alleviatesurinary incontinence by occluding the mid-urethra (for example at a timeof raised abdominal pressure by coughing or the like).

The sling is provided in the body using two large curved needles whichare provided at each end of the sling, which sling comprises a long meshor tape. Each of the needles is carried on an insertion tool (which isbasically a handle facilitating manipulation of the needles). The meshor tape is usually made of knitted polypropylene (such as Prolene®). Themesh or tape is generally covered with a plastics sleeve or polyetheneenvelope to aid smooth insertion, the mesh or tape having rough surfacesto aid retention in the body.

An incision is made in the anterior vaginal wall and the first of theneedles is passed through the incision, past one side of the urethra,behind the pubic bone, through the rectus sheath and out through thelower anterior abdominal wall. Likewise, the second needle is passedthrough the incision, past the other side of the urethra, behind thepubic bone, through the rectus sheath and out through the lowerabdominal wall. The needles are separated from their respectiveinsertion tools and also from the mesh or tape such that only the tapeand its plastics sleeve are left in the body, passing from a first exitpoint in the lower abdominal wall, through the rectus sheath, behind thepubic bone, under the urethra, back behind the pubic bone, back throughthe rectus sheath and out through a second exit point in the lowerabdominal wall.

The plastics sleeve is then removed from the tape and the tape adjustedto a suitable tension (such that the tape provides a sling that passesloosely under the urethra, as described above) by manoeuvring the freeends of the tape outside the exit points in the lower abdominal wallwhilst the urethra is held using a rigid catheter inserted therein. Thetape is then cut such that it just falls short of protruding from theexit points in the lower abdominal wall. The exit points and theincision in the upper vaginal wall are then closed by sutures. The tapeis held in position by virtue of friction between the tape's rough edgesand the surrounding body tissue (such as the rectus sheath and the bodytissue behind the pubic bone) and subsequent natural adhesion of thetape with the body tissue as it re-grows around the mesh material.Whilst highly effective in treating urinary incontinence, this procedurehas a number of problems. One such problem is that the needles used forinserting the tape are comparatively large, with the needles having, forexample, a diameter of around 5-6 mm and a length of around 200 mm. Aswell as causing concern for patients viewing such needles before orduring the procedure (which is carried out under local anaesthetic),this can also lead to a high vascular injury rate.

Similarly, the requirement that the needles exit the lower abdominalwall is disadvantageous due to the trauma to the patient in this areaand pain of such abdominal wounds. A further disadvantage is that thetape comprises a relatively large foreign body mass to be retainedwithin the patient and this can lead to related inflammation, infectiontranslocation, erosion, fistula and such like.

Similarly, the nature of the large needles and tape, along with thetools required to insert these in the body, lead to the procedure havinga relatively high cost.

According to a first aspect of the present invention there is provided asurgical implant for supporting the urethra, the implant comprising: asuburethral support suspended between at least two soft tissue anchorsattached at either side of the suburethral support, each soft tissueanchor having retaining means for retaining each anchor in tissue andsuspending means for suspending each side of the suburethral supportfrom a soft tissue anchor such that the suburethral support passes underthe urethra in use.

Preferably the retaining means of the soft tissue anchor is capable ofbeing inserted into soft tissue or fascia from an incision in the uppervaginal wall without the need to penetrate the lower abdominal wall.

In one embodiment the soft tissue anchor is insertable into the rectussheath of the human or animal body to anchor suspending means to thesoft tissue, the suspending means being attached to the soft tissueanchor and the soft tissue anchor having retaining means adapted toprevent retraction of the anchor from the rectus sheath in a directionopposite to that of insertion of the anchor into the tissue.

Preferably the soft tissue anchor comprises a central portion and theretaining means includes at least one wing section, the wing sectionbeing mounted on a first end of the central portion by resilient hingemeans such that the wing section is moveable between an open, restingposition and a deflected position such that in use, when the soft tissueanchor device is inserted into the tissue the wing section is pushed orheld towards the central portion to a deflected position to permit entryof the soft tissue anchor into the tissue and through the rectus sheath,wherein the wing section returns to its open or resting position andprevents the soft tissue being removed.

Preferably the resilient hinge means allows the wing section to returnto its resting position from its deflected position followingpenetration of the soft tissue anchor through the rectus sheath suchthat the wings of the soft tissue anchor once pushed through the rectussheath can rest on the surface of the rectus sheath fascia opposite tothe surface through which the soft tissue anchor is inserted and thusthe soft tissue anchor cannot be retracted.

Preferably the resilient hinge means is capable of preventing the wingsection being moved to a position greater than substantiallyperpendicular to the central portion.

Preferably the central portion of the soft tissue anchor comprises ahollow passage which extends from a first end of the central portion toa second opposite end of the central portion.

Preferably an introducing tool can be placed into the hollow passagesuch that the introducing tool extends through the central portion thesoft tissue anchor such that the introducing tool extends to a pointbeyond the first end of the central portion.

Preferably the soft tissue anchor comprises a plurality of wingsections.

More preferably the soft tissue anchor comprises four wing sectionsarranged radially around the first end of the central portion.

Preferably the soft tissue anchor in addition to comprising a centralportion and a wing section also comprises at least one stud elementarranged radially around the first end of the central portion, the studhaving an inclined face in the opposite direction to that in which thesoft tissue anchor is inserted to aid separation of the tissue duringentry of the soft tissue anchor enabling easier passage of the softtissue anchor through the soft tissue.

Preferably the soft tissue anchor does not comprise a sharp point.

In an alternative embodiment the soft tissue anchor is capable ofanchoring in the retropubic tissue space without penetrating the rectussheath.

Preferably the soft tissue anchor in this embodiment permits fixation atmultiple points via a christmas tree type configuration of deflectablewings.

A soft tissue anchor according to this embodiment comprises a centralportion and the retaining means includes a plurality of projections theprojections extending radially from the central portion along asubstantial portion of the length of the central portion allowingfixation at a plurality of layers. Preferably the projections extendradially from the central portion at an angle inclined toward the secondend of the central portion.

Preferably the projections are of a shape that they are able to provideadditive traction to the soft tissue anchor and allow it to gripfibro-fatty soft tissue and blood vessels of the para-uretheral tunnelbelow the level of the rectus sheath.

In yet a further embodiment the soft tissue anchor may comprise asubstantially flat head the bottom surface nearest the suspending meansof the flat head providing the retaining means which, in use is held inthe rectus sheath.

In a further embodiment the soft tissue anchor may comprise a sharppoint allowing it to pierce or penetrate the rectus sheath, andretaining means comprising a surface or protrusion directed rearwardlywith respect to the sharp point which does not cause the soft tissue topart and thus prevents the soft tissue anchor from being pulled back outthrough the rectus sheath soft tissue in the direction opposite to thatin which it is inserted into the soft tissue.

Preferably the sharp point is provided by the apex of a conical headportion and retaining means are provided by a substantially flat base ofthe conical head.

In any embodiment the soft tissue anchor is comprised of plasticsmaterial.

Typically the soft tissue anchor is comprised of polypropylene.

Alternatively the soft tissue anchor is comprised of absorbable materialso as to form temporary fixation in soft tissue.

The soft tissue anchor may comprise a point formed of absorbablematerial including polyglactin, the sharp point thus capable offacilitating insertion of the anchor, yet being absorbed by the bodylater.

Preferably the soft tissue anchor may be integral with the suspendingmeans.

More preferably the soft tissue anchor is integrally formed frompolypropylene or other polymeric material the attachment between theanchor and the suspending being formed as a single unit.

An integral construction of the soft tissue anchor and suspending meanshas the advantage of simplifying the construction of the soft tissueanchor and suspending means, which can reduce the possibility ofdefective manufacture etc. and reduce costs and the chance of the softtissue anchor and suspending means becoming detached once implanted inthe body.

Alternatively the soft tissue anchor is attached to the suspending meansby a thin metal tube crimped or otherwise attached around the suspendingmeans and central portion of the soft tissue anchor.

The suburethral support of the first aspect of the invention passesunder the urethra, loosely supporting the urethra, the suburethralsupport being held in position by suspending means attached to each ofits free ends on either side of the urethra, the suspending means beingattached at the opposite end to at least one soft tissue anchor.

Preferably the suburethral support is comprised of flat polymer tape.

Preferably the suburethral support has dimensions sufficient only topass around the urethra.

More preferably the suburethral support has dimensions of length 15-35mm, width 5-15 mm and thickness 50-350 μm.

In one embodiment the suburethral support has dimensions of length 25mm, width 10 mm and thickness 100 μm.

Preferably the suburethral support has at least two junctions to attachthe suburethral support to the suspending means.

One problem with the preferred arrangement of a soft tissue anchor andsuspending means for suspending the suburethral support of the surgicalimplant of the invention is that it is difficult to predetermine whatlength the suspending means must be to position the suburethral supportloosely under the urethra as desired.

This is because the distance between the rectus sheath in which the softtissue anchor is inserted and the urethra varies from patient topatient.

Preferably the distance between the soft tissue anchor(s) and thesuburethral support is adjustable.

More preferably the soft tissue anchor (or anchors) can be positionedfirst and the suburethral support then positioned by adjusting thelength of the suspending means.

Preferably the suburethral support is provided with at least oneattachment tab to which suspending means are releasably or permanentlyattached.

Preferably the suburethral support comprises an attachment tabcomprising a tunnelled element and an aperture, the tunnelled elementbeing located at each of the free ends of the suburethral support oneither side of the urethra at a position that the suspending means arecapable of being introduced through, the tunnelled element co-operatingwith the aperture such that suspending means can be passed through thetunnelled element and then through the aperture, the aperture beingpresent on the opposite surface of the suburethral support to that whichcontacts the urethra the aperture having an edge capable of co-operatingwith a ring element and the ring element being capable of being fittedaround the aperture trapping the suspending means between the ringelement and the edge of the aperture such that the suspending meansremain fixed in an adjusted position wherein the suburethra supporthanging loosely under the urethra.

Alternatively the attachment tab comprises at least one slot throughwhich suspending means can be passed, the suspending means beingpermanently attached to the slot by tying.

Alternatively the attachment tab comprises jamming slots that thesuspending means can be permanently attached by being threaded throughthe jamming slots such that the suspending means are held in an adjustedposition.

Alternatively the suburethral support is capable of being suitablypositioned under the urethra by altering the position of the soft tissueanchors within the body such that at least one soft tissue anchor issecured in the soft tissue or in the rectus sheath and a subsequentanchor is inserted into the soft tissue or rectus sheath to a suitabledepth such that the suburethral support hangs loosely under the urethra.

Alternatively the suspending means may be attached to the suburethralsupport by healing such that the suburethra support and/or suspendingmeans melt and form a join.

Alternatively the attachment tabs may have closure means for grippingthe suspending means.

The suspending means may be any means suitable for connecting each endof the suburethra support to the soft tissue anchor (or respective softtissue anchors).

Preferably the suspending means comprises a plastics strip.

Preferably the plastics strip has smooth edges.

Preferably the plastics strip comprises material such as polypropyleneor other suitable non-absorbable or absorbable polymer tape.

Preferably the plastics strip is 3-5 mm in width.

Preferably the plastics material comprises pores which extend throughthe plastics material from a first surface of the plastics material to asecond opposite surface of the plastics material said pores ranging inwidth across the surface of the plastics material from 50 μm to 200 μm,the pores allowing tissue in-growth to secure the strip in the body.

Alternatively the plastics material may comprise pits, that indent butdo not extend through the plastics material, on at least one of thesurfaces of the plastics material, the pits ranging in width from 50 μmto 200 μm, the pits allowing tissue in-growth to secure the strip in thebody.

Preferably the plastics material comprises pits or pores ranging inwidth across the surface of the plastics material from 100 μm to 150 μm.

Preferably the pits or pores are distributed across the complete surfaceof the plastics material.

Alternatively the pits or pores are distributed only in a particularportion of the surface of the plastics material.

Preferably the pits or pores are created by post synthesis modificationof the plastics material.

More preferably the pits or pores are created by post synthesistreatment of the plastics material by a laser.

Alternatively the pits or pores of between 50-200 μm are created duringsynthesis of the plastics material by spaces between the waft and weaveof mono-filament or multi-filament yarns when the filaments are woven toform a mesh.

Alternatively pits or pores formed during the synthesis of plasticsmaterial are formed by the inter-filament spaces created whenmono-filaments are twisted to create multi-filaments, themulti-filaments then being woven to form a mesh.

In an embodiment the suspending means is provided with a plurality ofmicrogrooves of width between 0.5-7 μm and of depth 0.25-7 μm on atleast one surface of the plastics strip.

Preferably the microgrooves are 5 μm in width and 5 μm in depth.

Preferably the plurality of microgrooves are aligned such that they aresubstantially parallel with each other.

Preferably the plurality of microgrooves are aligned such that they areseparated by ridges which range in size between 1-5 μm in width.

More preferably the microgrooves are separated by ridges of 5 μm inwidth.

Preferably the ridges are formed by square pillars and the base of themicrogroove is substantially perpendicular to the square pillars.

Alternatively the ridges are formed by square pillars and the base ofthe microgroove is bevelled in relation to the pillars.

Preferably the microgrooves are present on at least one surface of thesuspending means.

More preferably the microgrooves are present on a plurality of surfacesof the suspending means.

These microgrooves act to orientate and align the proliferatingfibroblasts on the surface of the plastics material and cause axialalignment of collagen fibres and formation of at least one strongordered neoligament.

The orientation and alignment of the proliferating cells is capable ofadding mechanical strength to the tissue which forms around the plasticsmaterial such that it is more able to support the urethra.

Preferably the suburethral support of the present invention has neitherpores, pits or grooves to discourage the formation of peri-urethraladhesions.

According to a second aspect of the present invention there is provideda method of supporting the urethra comprising the steps of, introducinga surgical implant as described above into an incision made on the upperwall of the vagina, inserting a soft tissue anchor on a first side ofthe urethra behind the pubic bone, inserting a second soft tissue anchoron a second side of the urethra behind the pubic bone, such that thesuburethral support is suspended from the soft tissue anchor supportsthe urethra.

The invention also provides the use of the method of supporting theurethra in treating urinary incontinence or uterovaginal prolapse.

In one embodiment of the method the soft tissue anchors are inserted inthe rectus sheath.

In an alternative embodiment of the method the soft tissue anchors areinserted in the fibro-fatty soft tissue of the retropubic tissue spaceand do not penetrate the rectus sheath.

The invention also provides an introducing tool comprising an elongatehousing adapted to receive the soft tissue anchor at one end and a pointwhich is capable of extending through the central portion of a softtissue anchor for use in carrying out the method of the invention suchthat the introducing tool enables access and placement of the softtissue anchor through the rectus sheath or in the fibrous fatty softtissue of the para-urethral tunnel from an insertion point in the uppervaginal wall.

More preferably the elongate housing is curved or bent, preferablythrough an angle of approximately 30°.

It is desirable such that a sharp point of an anchor not is not retainedin the body that the soft tissue anchor may be inserted using anintroducing tool the introducing tool having a sharp point forpenetrating the soft tissue.

Preferably an introducing tool comprises a sharp point for piercing orpenetrating soft tissue and carrying means for carrying the soft tissueanchor to insert the anchor into the tissue such that the soft tissueanchor device does not require a sharp head and no sharp point is leftin the body.

The overall size of the soft tissue anchor and introducing tool may besignificantly smaller than that of the needles of the prior art.

Preferably the introducing tool may have a diameter of around 2 mm to 4mm.

Preferably if the introducing tool is to be used in co-operation with asoft tissue anchor comprising a plurality of projections extendingradially from the central portion along a substantial portion of thelength of the central portion of the soft tissue anchor, the introducingtool comprises containment means for radially confining the plurality ofprojections extending from the central portion of the soft tissue anchorduring the insertion of the soft tissue anchor.

Thus, when the soft tissue anchor has been inserted, the tool mayrelease the retaining means around the soft tissue anchor such that theprojections which have memory are biased to expand radially and grip thesoft tissue.

The reduced size of the introducing tool in comparison to the needlesused to introduce devices of the prior art can significantly reduce thevascular injury rate and perceptual problems of the prior art for apatient.

Preferably the introducing tool is able or has means for releasablyretaining the soft tissue anchor on the end of the housing.

During the insertion of a surgical implant to support the urethra thereis a risk of penetration of the bladder wall by the needles duringinsertion of the tape.

This is known to be a problem with the TVT procedure described by theprior art where the needles are inserted through an incision in thevagina to thread the tape through the respective punctures in the loweranterior abdominal wall.

Following the TVT procedure of the prior art it is thereforeconventional to carry out cystoscopy after the tape has been inserted inthe body to determine whether or not the bladder has been perforated.This is painful for the patient and also increases the duration of theoperation.

The reduced size of the tools used for inserting the surgical implant ofthe present invention reduce to some degree the risk of the bladderbeing perforated during the surgical procedure, however it isnevertheless desirable to reduce the need for cystoscopy.

Accordingly at least a part of the surgical implant of the presentinvention may be coated or impregnated with a water soluble dye.

Preferably the soft tissue anchor of the present invention isimpregnated with a water soluble dye.

Preferably, the water soluble dye is methylene blue.

It is possible to determine whether or not the bladder of a patient hasbeen perforated by a surgical implant or instrument when inserting thesurgical implant of the invention into the body, by expelling a smallamount of fluid from the bladder, and determining whether or not thissmall amount of fluid contains any dissolved dye.

Should the bladder be perforated on insertion and placement of thesurgical implant into the body, the dye impregnated into the surgicalimplant will dissolve in the fluid contained in the bladder and diffusenaturally throughout the fluid.

Thus should dye be present in the fluid, it is very likely that thebladder has been perforated and cystoscopy should be carried out. Ifthere is no dye in the fluid, the bladder has not been perforated andthe need for cystoscopy is obviated.

The soft tissue anchors as described in relation to the implant of thepresent invention are capable of use in a variety of situations.

Accordingly the invention provides soft tissue anchors as describedherein.

The invention also provides the use of the soft tissue anchors in herniarepair, face lifts, plastic surgery and cosmetic surgery.

Preferred embodiments of the present invention will now be described, byway of example only, with reference to the accompanying drawings, inwhich:

FIG. 1 is an illustration of a surgical implant according to theinvention,

FIGS. 2A and 2B are line drawings of the suspending means attached tothe suburethral support, positioned underneath the urethra,

FIG. 3 is an illustration of one embodiment of a suburethral support,

FIG. 4 is an illustration of a second embodiment of a suburethralsupport,

FIG. 5 shows suspending means being threaded through an attachment tabof a suburethral support,

FIGS. 6A, 6B and 6C show alternative methods of attaching suspendingmeans to a suburethral support,

FIGS. 7A, 7B and 7C are illustrations of a soft tissue anchor forinsertion through the rectus sheath,

FIGS. 8A, 8B and 8C are sequential illustrations of insertion of a softtissue anchor of FIGS. 7A, 7B and 7C.

FIG. 9 is an illustration of a soft tissue anchor mounted on anintroducing tool,

FIG. 10 is an illustration of a retropubic soft tissue anchor for use inthe fibro-fatty tissues of the para-urethral tunnel,

FIG. 11 is an illustration of the placement of a soft tissue anchor ofFIG. 10,

FIG. 12 is an illustration of an implanting tool and a soft tissueanchor inserted into the rectus sheath,

FIG. 13 is an illustration of the surgical implant implanted into therectus sheath,

FIG. 14 is an illustration of the prior art contrasted with thetechnique of the present invention,

FIG. 15 is an illustration of the tool used to insert the surgicalimplant, and

FIG. 16 is an illustration of the surface architecture of the suspendingmeans.

Referring to FIG. 1, a surgical implant for treating female urinaryincontinence has a suburethral support 10, suspending means 20 and atleast two soft tissue anchors 30, the suburethral support 10 beingpositioned in use, loosely under the urethra. The suburethral supporthas a length L of around 25 mm and a width W of around 10 mm such thatit passes around the urethra with a minimum of excess material, althoughother similar dimensions would also be suitable. In this example, thesuburethral support 10 is made from flat polymer tape. At each side11,13 of the suburethral support 10 suspending means 20 are providedwhich attach to the suburethral support 10 at a first end 22,24.

The suspending means 20 are attached at a second end 26 to a respectivesoft tissue anchor 30.

As shown in FIGS. 7A, 7B and 7C the soft tissue anchor 30 of theembodiment described comprises a central portion 32 and four wingedsections 34 which are attached to the central portion at a first end 38by resilient hinge means 36 and radially extend from the central portion32 such that when viewed from the front the anchor device resembles across.

As shown in FIG. 8A the wing sections 34 of the soft tissue anchor 30having a resting position in which they are inclined towards the rear 40of the central portion 32 at an angle of around 45°. In FIG. 8B duringpenetration of the anchor through tissue (the point 60 of theintroducing tool enabling the soft tissue anchor to be pushed throughthe tissue and rectus sheath 120) the wing sections 34 of the softtissue element 30 may adopt a deflected position which means thepenetration of the soft tissue anchor through the tissue and rectussheath 120 is more effective.

As shown in FIG. 8C once the rectus sheath 120 has been pierced theresilient hinge means 36 cause the wing sections 34 to return to theirresting position.

Movement of the soft tissue anchor in a direction opposite to which itwas introduced into the soft tissue causes the wing section to bedeflected until an endstop 46 is reached which prevents the wingsections 34 moving beyond a point substantially perpendicular to thecentral portion 32 and prevents retraction of the soft tissue anchor 30from the soft tissue.

The soft tissue anchor 30 further comprises a hollow portion 48 whichextends from the first end 38 to the second rear end 40 of the centralportion 32 through which an introducing tool 50 may be placed.

The introducing tool 50 extends through the hollow portion 48 such thatit extends as a sharp point 60 from the first end 38 of the soft tissueanchor 30 such that the sharp point 60 allows penetration of the tissueby the soft tissue anchor 30.

Stud like projections 42 which extend radially from the central portion32 are angled such that they extend further radially from the centralportion 32 as they extend towards the rear 40 of the central portion 32,this inclination allowing the soft tissue anchor 30 to pass more easilyinto the soft tissue.

A recessed portion 44 is positioned toward the rear end 40 of thecentral portion 32 to facilitate attachment of the suspending means 20to the soft tissue anchor 30.

The suspending means 30 may be respectively attached to the soft tissueanchor 30 at this recessed point 44 by crimping a tube around thesuspending means 20 to fix the suspending means 20 to the soft tissueanchor 30.

In the embodiment shown the soft tissue anchor may be suitablypositioned in the rectus sheath 120 using an introducing tool 50. Asshown in FIG. 15 the tool 50 comprises a handle 52 and elongate body 54.The elongate body 54 is curved through an angle of approximately 30° tofacilitate positioning of the soft tissue anchor 30 in the rectus sheathor surrounding soft tissue of the human body from an incision in theupper wall of the vagina (as described below). The soft tissue anchor 30is located on the elongate body at a narrowed portion 58 of theintroducing tool such that the soft tissue anchor is held in place by anabutment 56 such that the narrowed portion 58 may extend through thehollow portion 48 of the soft tissue anchor 30 such that the point 60 ofthe insertion tool 50 protrudes from the first end 38 of the soft tissueanchor and allows the soft tissue anchor to be inserted into the humanbody through the soft tissues and more specifically through the rectussheath 120 during the placement of the soft tissue anchor.

The placement of the soft tissue anchor 30 on the insertion tool 50 isshown in FIGS. 8B and 8C, which shows the soft tissue anchor 30 beingpushed through soft tissue fascia, such as the rectus sheath 120. Oncethe soft tissue anchor has penetrated the rectus sheath fascia 120, asshown in FIG. 8B, the introducing tool 50 can be withdrawn, as shown inFIG. 8C, leaving the soft tissue anchor 30 in place.

As shown in FIG. 9 the soft tissue anchor may alternatively be comprisedof a central portion 70 and a plurality of projections 72 theprojections extending radially from the central portion 70 and arrangedalong a substantial portion of the length of the central portion 70. Theprojections 72 may be of any shape such that they provide resistancewithin the fibro-fatty soft tissue and blood tissues of thepara-urethral tunnel in the direction opposite to that in which the softtissue anchor is introduced.

This resistance is also provided by the multiple layers, typicallybetween 5-10 layers of projections 72 which extend from the centralportion 70.

Using these multiple layers of projections 72 it is not necessary toinsert the soft tissue anchor through the rectus sheath 120. Instead thesoft tissue anchor should be positioned as high in the retropubic spaceas possible in the fibro-fatty soft tissue.

In the embodiment of the soft tissue anchor comprising multiple layersof projections 72 which resembles a christmas tree, as shown in FIG. 10,the introducing tool comprises a collar which releasably retains theprojections during insertion into the retropubic space. The collar maycomprise a semi-sharp bevelled needle. Following insertion of thechristmas tree like anchor into the fibro-fatty soft tissue of theretropubic space the introducing tool is withdrawn removing the collarfrom around the plurality of projections 72 of the soft tissue anchor,which due to their memory expand outwards from the central portion 70and grip the fibro-fatty soft tissue of the retropubic space at multiplelayers. The collar of the introducing tool which extends around the softtissue may contain a cross-sectional opening such that once the tool iswithdrawn the collar may be removed from the surgical implant by passingthe implant through the cross-sectional opening.

Accordingly the invention also provides an introducing tool for use ininserting the soft tissue anchor.

Suspending means 20 attached to the soft tissue anchors are formed froma strip of plastics material such as polypropylene which is sufficientlysoft to avoid damaging the urethra or surrounding body tissue andsuitably inert such that it can be left in the human body for a longperiod of time without causing adverse reactions. Again, other suitablematerials will be apparent to those skilled in the art.

The polypropylene mesh strip of 3-5 mm in width which forms thesuspending means 20 has smooth edges to avoid adhesion of the softtissue to the strip, reducing problems associated with leaving foreignmaterial in the human body for long periods of time. As shown in FIG. 16the polypropylene mesh strip further comprises pores or pits 80 rangingin width across the surface of the strip from 50 μm to 200 μm, whichextend through the strip from a first surface of the strip 26 to asecond opposite surface 28 of the strip the pores 80 allowing tissuein-growth to secure the suspending means 20 in the body.

The pores 80 are created by post synthesis treatment of thepolypropylene mesh material by a laser.

The polypropylene mesh which forms the suspending means 20 alsocomprises microgrooves 82 of width 5 μm and of depth 5 μm on thesurfaces of the polypropylene mesh.

The microgrooves 82 are aligned such that they are substantiallyparallel with each other and separated by ridges of around 5 μm inwidth.

The ridges are formed by square pillars the base of the microgroovebeing substantially perpendicular to the square pillars or bevelled inrelation to the pillars. The microgrooving 82 being present on bothsurfaces of the suspending means to orientate and align theproliferating fibroblasts on the surface of the plastics material andcause axial alignment of collagen fibres and formation of at least onestrong ordered neoligament.

This orientation and alignment of the proliferating cells addingmechanical strength to the tissue which forms around the plasticsmaterial such that it is more able to support the urethra.

The suburethral support is not provided with pores, pits or grooves todiscourage the formation of peri-urethral adhesions.

Once the soft tissue anchors have been suitably positioned in either thesoft tissue of the para-urethral tunnel or through the rectus sheath 120the length of the suspending means 20 can be altered such that thesuburethral support 10 hangs loosely under the urethra.

As shown in FIGS. 2A and 2B, the suspending means 20 are attached at afirst end 22, 24 to the sides 12, 14 of the suburethral support 10,which extend on either side of the urethra.

As shown in FIGS. 6A-6C, a preferred method of altering the length ofthe suspending means 20 attached to the suburethral support 10 comprisesa tunnelled element 13 at each of the free ends 22,24 of the suburethralsupport 10 on either side of the urethra. The tunnelled element 13extends from the edges of the suburethral support 10 to an aperture 15,the aperture being present on the opposite surface 16 of the suburethralsupport 10 to the surface which contacts the urethra 17, the aperture 15having an edge 18 able to co-operate with a ring element 19 such thatthe ring element which has memory can be pushed onto the edge 18 of theaperture 15 trapping the suspending means 20 between the edge of theaperture 18 and the ring element 19 thus securing the suburethralsupport 10 along a particular desired length of the suspending means 20such that the suburethra support 10 hangs loosely under the urethra.

FIG. 5 shows an alternative method of attaching the suspending means 20to the suburethral support 10, the suspending means 20 being threadedthrough jamming slots 12 such that the suspending means 20 arepermanently attached to the jamming slots 12 by being pulled into thejamming slots 12 as shown in FIG. 5 such that the suspending means isheld tightly in position.

Alternatively, the suspending means 20 may be passed through slots andthe suspending means permanently attached to the slots by tying.

In use, as shown in FIG. 12 the soft tissue anchor 30 is placed on theintroducing tool 50 as described above. An incision 117 is made in theupper wall 116 of the vagina, as shown in FIG. 11, and the introducingtool 112 is passed through the incision 117, past one side of theurethra 118, behind the pubic bone 119 and into the rectus sheath 120.It is apparent to the surgeon when the rectus sheath 120 has beenpenetrated as this stage of insertion presents significant resistance.Once the head 58 of the introducing tool 50 and the soft tissue anchor30 have passed through the rectus sheath 120, the resistance diminishesand the surgeon ceases to insert the introducing tool 50.

The introducing tool 50 is retracted from the body releasing the softtissue anchor 30. Due to the wing sections 34 on the central portion 32of the soft tissue anchor 30, the soft tissue anchor 30 is retained bythe rectus sheath 120 as the introducing tool 50 is retracted. Thus, thesuspending means remains in the body, secured by the soft tissue anchorwhich is opposed by the rectus sheath 120.

This procedure is repeated, with a second soft tissue anchor 30 andsuspending means 20, with the introducing tool 50 being passed throughthe incision 117 and past the other side of the urethra 118. Thus, twosuspending means 20 are provided, attached to the rectus sheath 120, onepassing either side of the urethra 118.

The suspending means 20 are passed through the tunnelled elements 13 ofthe suburethral support 10, and the suspending means 20 are pulledthrough the aperture 15 until the suburethral support 10 is positionedsuch that it passes under the urethra 118. The suspending means 20 arethen fixed in place by placing a ring element 19 over the edge 18 of theaperture 15 such that the suspending means are trapped between the edge18 and the ring element 19 securing them in place.

FIG. 12 is an illustration of an introducing tool 50 and a soft tissueanchor 30 connected to a suspending means 20 (as shown a suture, orfilament) with the soft tissue anchor 30 inserted into the rectus sheath120. As shown, the urethra 118 is illustrated relative to the bladder121 and the incision 117 has been formed in a wall of the vagina 116.The introducing tool 50 has a handle 52 and an elongate body 54. Theelongate body 54 has an eye 15, or hole, toward its distal end. The softtissue anchor 30 is secured to the distal end of the elongate body 54and the filament extends from the soft tissue anchor 30 with the freeend of the filament passed out through the hole 15 formed in theelongate body 54. The free end of the filament is then pulled throughthe hole 15 until the soft tissue anchor 30 is located at the distal endof the elongate body 54. As shown, the free end of the filament extendsalongside the elongate body 54. FIG. 13, in turn, is an illustration ofthe suburethral support 10 connected to the filament with the softtissue anchor 30 and the filament released from the introducing tool 50.

In this example, a portion of the surgical implant is impregnated withmethylene blue, which is a harmless water soluble dye. At the end of theprocedure a small amount of fluid is expelled from the bladder 121.Should this fluid contain any dissolved methylene blue, it is verylikely that the bladder has been perforated on placing the soft tissueanchor 30. In this case, cystoscopy should be carried out. If nomethylene blue is present, the need for cystoscopy is advantageouslyobviated. Other suitable water-soluble dyes may, of course, be used.

Referring to FIG. 14, it can be appreciated that the surgical implant ofthe present invention, when inserted in the human body, may extend fromthe rectus sheath 120, through the paraurethral space 130 on one side ofthe urethra 118, around the urethra and back to the rectus sheath 120 onthe other side. In contrast, the prior art device comprises a tape 200that also extends through the abdominal wall 127 and represents a fargreater implanted mass.

Referring to FIG. 11, in use, the further embodiment of soft tissueanchor illustrated in FIG. 9 for placement in fibro-fatty soft tissue ofthe retropubic space is placed on an introducing tool. An incision 117is made in the upper wall 116 of the vagina, as shown in FIG. 11, andthe introducing tool 112 is passed through the incision 117, past oneside of the urethra 118, and located in the fibro-fatty soft tissue andblood vessels of the para-urethral tunnel. In this case the surgeon doesnot introduce the soft tissue anchor as far into the body as describedpreviously and the rectus sheath 120 is not penetrated. Once the softtissue anchor has been suitably positioned in the soft tissue thesurgeon ceases to insert the introducing tool and retracts theintroducing tool from the body releasing the projections of the softtissue anchor 72. The release of the projections 72 of soft tissueanchor by the introducing tool allows the projections to grip the softtissue surrounding the soft tissue anchor and provide resistance tomovement of the soft tissue anchor in a direction opposite to that whichit was inserted.

This procedure is repeated, with a second soft tissue anchor such thatthe projections 72 of the soft tissue anchor also provide resistance tomovement of the soft tissue anchor in a direction opposite to that whichit was inserted the introducing tool being passed through the incision117 and past the other side of the urethra 118.

Thus, two suspending means 20 are provided, which are held in the softtissue comprising fibro-fatty tissue and blood vessels.

As described above the suspending means 20 are passed through theattachment tabs of the suburethral support 10, and the suburethralsupport 10 positioned such that it passes under the urethra 118.

Again this device contrasts that described by the prior art device inthat it does not extend through the abdominal wall 127 and does notrepresent as much implanted mass.

Various embodiments of the present invention can be envisaged within thescope of the invention, for example the soft tissue anchor may comprisea cone or a half cone such that a circular or semi-circular base isprovided as a retaining means to prevent retraction of the soft tissueanchor in a direction opposite to that in which it is inserted into thetissue.

Alternatively the soft tissue anchor may comprises a substantially flator disc shaped head. In this case the introducing tool may have aconical head with a sharp point at its apex and a slot for receiving theflat or disc shaped head.

In yet another example, the soft tissue anchor may be formed of twosections. The upper section, i.e. the portion of the anchor that formsthe sharp point 10, may be made from an absorbable material, such aspolyglactin such that a sharp point is provided for insertion of theanchor into the body, but this sharp point is later absorbed by the bodyso as to eliminate any discomfort or disadvantage caused by a sharppointed object being retained inside the body.

The soft tissue anchor may be made from metal, such as titanium, as thisis a hard material that can easily be formed into the head having thesharp point at its apex, and is sufficiently malleable to provide a tubethat may be crimped to the suspending means.

What is claimed is:
 1. A system for treating urinary incontinence by providing support to a urethra of a patient, the system comprising: a suburethral support formed of a mesh material and being substantially rectangular in shape, the suburethral support defining a first end portion and a second end portion, the first end portion located opposite the second end portion; a first soft tissue anchor coupled to the first end portion of the suburethral support and a second soft tissue anchor coupled to the second end portion of the suburethral support, the first soft tissue anchor having a base, an apex opposite the base, and a plurality of barbs adapted for soft tissue anchoring, the second soft tissue anchor having a base, an apex opposite the base, and a plurality of barbs adapted for soft tissue anchoring; a first filament connected to the base of the first soft tissue anchor and a second filament connected to the base of the second soft tissue anchor; and an introducer having an elongate shaft and a handle, the elongate shaft having a distal portion and a proximal portion, the elongate shaft being coupled at the proximal portion to the handle, the distal portion of the elongate shaft defining an aperture adapted to receive the first filament, the distal portion of the elongate shaft having a terminal end adapted to engage with the first soft tissue anchor.
 2. The system of claim 1, wherein the first filament is attached around a portion of the base of first soft tissue anchor.
 3. The system of claim 1, further comprising a second filament connected to the base of the second soft tissue anchor.
 4. The system of claim 1, wherein the terminal end of the distal portion of the elongate shaft is adapted to releasably couple to the base of the first soft tissue anchor.
 5. The system of claim 1, wherein the base of the first soft tissue anchor defines a first section and a second section, the first section having a first width and the second section having a second width, the second width being greater than the first width.
 6. The system of claim 5, wherein the first section of the base of the first soft tissue anchor is adapted for securing the first filament to the first soft tissue anchor.
 7. The system of claim 5, wherein the first section of the base of the first soft tissue anchor defines a recessed portion of the base.
 8. The system of claim 1, wherein the plurality of barbs of the first soft tissue anchor have surfaces directed rearwardly with respect to the apex of the first soft tissue anchor such that the first soft tissue anchor substantially resists being pulled back through soft tissue in a direction opposite to that in which the first soft tissue anchor was inserted.
 9. The system of claim 1, wherein the second soft tissue anchor has an apex opposite a base and a plurality of barbs adapted for soft tissue anchoring.
 10. A method for treating urinary incontinence by providing support to a urethra of a patient, the method comprising: making a vaginal incision for securing a suburethral support under a urethra of a patient, the suburethral support being formed of a mesh material, defining a substantially rectangular outer profile, and having a first end portion and a second end portion; passing a first filament through an aperture of a first introducer, the first filament being connected to a base of a first soft tissue anchor, the first soft tissue anchor including a plurality of barbs and an apex opposite the base, the first introducer having an elongate shaft and a handle, the elongate shaft having a distal portion with a terminal end and a proximal portion coupled to the handle, the distal portion of the elongate shaft defining the aperture adapted to receive the first filament; releasably coupling the first soft tissue anchor with the first introducer by advancing the first introducer over the first filament until the first soft tissue anchor engages the terminal end of the distal portion of the elongate shaft; inserting the first soft tissue anchor through the vaginal incision and penetrating soft tissue by pressing the apex of the first soft tissue anchor into the soft tissue on a first side of the urethra using the first introducer.
 11. The method of claim 10, further comprising attaching the first filament around a portion of the base of the first soft tissue anchor.
 12. The method of claim 10, further comprising pulling the first filament to generate tension and bringing the base of the first soft tissue anchor against the terminal end of the elongate shaft of the first introducer.
 13. The method of claim 12, further comprising decoupling the first soft tissue anchor from the first introducer by releasing the tension on the first filament and retracting the first introducer.
 14. The method of claim 10, further comprising repositioning the first soft tissue anchor by one of advancing and retracting the first introducer in cooperation with the first soft tissue anchor.
 15. The method of claim 10, further comprising passing a second filament through one of the aperture in the first introducer or an aperture of a second introducer, the second filament being connected to a base of a second soft tissue anchor, the second soft tissue anchor including a plurality of barbs and an apex opposite the base. 